Hydra Registry - UK
Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Sahajanand Medical Technologies Limited
250 participants
Jul 11, 2024
OBSERVATIONAL
Conditions
Summary
The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.
Eligibility
Inclusion Criteria3
- Patients with severe aortic stenosis eligible for transfemoral TAVI procedure as per local Heart Team evaluation
- Full understanding and willing to provide informed consent to study enrolment
- Age ≥ 18 years
Exclusion Criteria4
- Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- Refusal to provide informed consent to study enrolment
- Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
- Patients with significant calcification of the aortic annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator.
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Interventions
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06507579